Manufacturing Engineer II
Manufacturing Engineer II
The DAVIS Companies is supporting a global leader in the medical device industry by securing a Manufacturing Engineer II for their team.
The Manufacturing Engineer II provides manufacturing engineering and technical support to manufacturing, cost reduction and product development projects. This includes equipment and process development, validations, and troubleshooting. Performs various engineering assignments that support the organizations objectives.
Responsibilities of Manufacturing Engineer II:
- Applies engineering principles in managing, supporting, and maintaining the production of new and existing products and implementation of design changes and product improvements.
- Plans, schedules, conducts, and coordinates detailed phases of the engineering project or work as part of a major project.
- Performs independently on most assignments with instructions as to the general results expected. Documents work and reviews progress and results with manager.
- Designs and develops production processes, fixturing and equipment.
- Develops IQ/OQ/PQ protocols, conducts testing and writes reports for products and manufacturing equipment for processes validation.
- Develop and optimize work instructions and procedures.
- Identifies the root cause of manufacturability yield and specification issues, implements corrective actions for those relating to design, and communicates findings to other team members or to those responsible for other types of issues.
- Work with quality to develop root cause/corrective actions on non-conformances.
- Interfaces with Production, Quality, customer engineering, and/or supplier to resolve manufacturing, quality, equipment, product design, and/or component issues so as to meet company’s objectives.
- Works cross functionally with Production, Quality, customer engineering to establish project requirements, planning, analysis, implementation and progress.
- Implements product quality and process improvement programs.
- Communicates well orally and in writing. Able to present ideas and proposals to all levels of the organization.
- Generates engineering documentation (specifications, risks analysis, drawings, reports, protocols, revisions, etc.).
- Participates in design reviews. Communicates with applicable resources to assess manufacturing feasibility and potential issues of product changes and new products.
- Reviews and signs quality records and engineering documents as applicable.
- Implements cost reduction and margin improvement programs.
- Complies with applicable safety rules and recommendations.
Education and Experience Required of Manufacturing Engineer II:
- Bachelor's degree in Engineering or related field.
- Minimum of 3 years of Manufacturing/Sustaining engineering experience.
- Minimum of 1-2 years of medical device experience.
- Working knowledge of IQ/OQ/PQ and PPQ.
- Proficient in SolidWorks/AutoCad, Minitab, and Microsoft Office Applications (Microsoft Word, Excel and PowerPoint).
- Experience working in an ISO/FDA regulated industry and manufacturing environment preferred.
- Experience in writing and maintaining technical documentation.